Daunorubicin and Cytarabine Liposome for Injection
68727-0745-XX Vyxeos 44-100 MG Solution Reconstituted (JAZZ PHARMACEUTICALS)
Daunorubicin and cytarabine liposome for injection is a combination of daunorubicin and cytarabine at a molar ratio of 1 to 5 encapsulated in liposomes for administration by intravenous infusion. Daunorubicin is an anthracycline topoisomerase inhibitor. Cytarabine is a nucleoside metabolic inhibitor. At that particular fixed ratio, they work together synergistically at killing leukemia cells. Daunorubicin inhibits DNA polymerase activity and produces DNA-damaging free radicals. Cytarabine works as a cell cycle phase-specific antineoplastic agent during the S-phase of cell division. Liposomes enter and re taken up by the bone marrow where they persist. They appear to be taken up by leukemic cells more readily than normal bone marrow cells. They then undergo degradation and release the daunorubicin and cytarabine within the bone marrow cellular environment.
Daunorubicin and cytarabine liposome for injection for the treatment of therapy related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Daunorubicin and cytarabine liposome for injection for the treatment of other conditions/diseases is considered investigational.
Daunorubicin and cytarabine liposome for injection is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Individual has baseline left ventricular ejection fraction (LVEF) within normal limits
Cumulative lifetime anthracycline (e.g., daunorubicin, etc.) dose does not exceed 550 mg/m2 (or 400 mg/m2 in individuals who received radiation to the mediastinum)
Treatment will not be used in combination with other chemotherapy
Used for ANY ONE of the following:
Individual has newly diagnosed disease
Used for re-induction after standard-dose cytarabine induction for ANY ONE of the following:
Individual > 60 years with residual disease
Individual < 60 years with significant residual disease in the absence of a hypocellular marrow and core binding factor (CBF) abnormalities
Used post-remission for ANY ONE of the following:
Individual > 60 years with complete response to previous intensive therapy
Individual < 60 years in the absence of core binding factor (CBF) abnormalities, treatment-related disease, poor-risk cytogenetics, or molecular abnormalities
Daunorubicin and cytarabine liposome for injection is NOT considered medically appropriate for renewal.
DOSAGE & ADMINISTRATION
t-AML & AML-MRC
· daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome intravenously days 1, 3 and 5
· daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 liposome intravenously days 1 and 3
· daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 liposome intravenously days 1 and 3
LENGTH OF AUTHORIZATION
Coverage will be provided for a maximum of 2 cycles of induction (5 doses total) and 2 cycles of consolidation (4 doses total) within 6 months. Coverage may not be renewed.
Refer to DOSAGE LIMITS below
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENT
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Lexi-Comp Online. (2019). AHFS DI. DAUNOrubicin and Cytarabine. Retrieved August 15, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (May, 2019). DAUNORUBICIN AND CYTARABINE, LIPOSOME. Retrieved August 15, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Cytarabine/daunorubicin liposome. Retrieved August 15, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, August). Center for Drug Evaluation and Research. VYXEOS™ (daunorubicin and cytarabine) liposome for injection, for intravenous use. Retrieved August 14, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 9/12/2017
MOST RECENT REVIEW DATE: 10/8/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit
1 billable unit = 1 mg daunorubicin and 2.27 mg cytarabine